MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD STIMULATOR

Model Number FR8A-TRL-A0, FR8A-TRL-B0

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, the patient had an appointment with the implanting clinician to get her leads pulled from the scs trial.The implanting clinician was unable to locate the leads and decided to perform x-rays.The implanting clinician was able to identify that one of the leads had migrated and advanced from t-9 to t-2.The implanting clinician chose to remove the lead during the permanent implant date scheduled for (b)(6) 2020.The patient was prescribed antibiotics in preparation for the revision.On august 18, 2020, the cr disclosed that on (b)(6) 2020, the implanting clinician explanted via laminectomy stimulator serial number (b)(4) and successfully implanted two permanent freedom-8a neurostimulator at the t8 thoracic spinal nerve.On (b)(6) 2020, the cr followed up with the patient on her condition's status.The patient disclosed the incision site is healing well, she has not had any further issues, and she is receiving pain relief from the stimulator.The stimulator was reported to meet product specifications.Manufacturer cannot currently receive the stimulator for analysis.The device was used for treatment of pain.The device cannot be traced as the source of the issue.Metal migration is a known adverse event for peripheral nerve stimulator that is reduced as far as possible in the product's risk management file.Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for lot swo200206 and swo200227, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.

Event Description

Stimwave quality has investigated the details for a reported migration to the stimwave complaint system on august 4, 2020, by clinical representative (cr) in the united states.Cr became aware of this issue (b)(6) 2020.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10456720
• MDR Text Key: 213254062
• Report Number: 3010676138-2020-00127
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO200206, SWO200227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention